Reversing Warfarin

The next issue of The Medical Letter (July 8, 2013) will include an article on a 4-factor prothrombin complex concentrate that was recently approved by the FDA to reverse the anticoagulant effect of warfarin in patients with serious bleeding. Someone at the FDA once told us that he wouldn’t be surprised if warfarin caused more problems than all the other drugs in the pharmacopoeia put together. I guess he was exaggerating, but you get the idea.

Of course this new product is not the first remedy for warfarin-induced bleeding. Vitamin K is a direct antidote for warfarin, but it can take a long time to stop the bleeding, and emergency department physicians usually reach for something else as well. Fresh frozen plasma is usually available, and it can be effective in an hour or two, but it has to be thawed and type and cross is required. Prothrombin complex concentrates don’t have these restrictions, and they can stop the bleeding about as fast as fresh frozen plasma can. The problem has been that the most complete prothrombin complex concentrate, the one that replaces all four of the vitamin-K-dependent coagulation factors, has not, up to now, been available in the US.

We have been making do with 3-factor plasma complex concentrates, which contain little or no factor VII. To make up for the missing factor, some clinicians have been giving recombinant factor VII or fresh frozen plasma in addition to 3-factor PCC. But now we have the complete product. Not for nothing, of course, and not without side effects of its own. Keep bleeding or risk a thromboembolism? Before long, I fully expect some high-minded advisory group to recommend that we discuss the options with the patient and let him or her decide. You won’t see that in The Medical Letter.

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